In the past decade, a number of new and effective therapies have been developed for the treatment of diabetic retinopathy (DR). Such therapies are only effective if administered prior to irreversible retinal damage which can occur if diabetics who are at high risk for developing the more advanced stages of diabetic retinopathy fail to get even the annual eye exams recommended by AAO, ADA and AMA.. Vital Art and Science Incorporated (VAS) was founded by a multi-disciplinary group of researchers and business people to specifically address this problem by creating a low cost and easy to use diagnostic tool which enables the patient to conveniently monitor their own DR progression at home and seek medical intervention at the earliest signs of visual loss. The VAS goals are to clinically validate and then commercialize a sub-$100 home vision function monitor that healthcare providers could prescribe to their diabetic patients for much more frequent screening to help detect critical changes in the retina so they can be examined and treated at the earliest possible time to maximize the effectiveness of therapeutic intervention and minimize preventable loss of vision. This project is a continuation of our Phase I where a first generation vision function test was developed and successfully tested in a 40 DR/DME patient, 6 month Study verifying that patients could and would effectively use our home vision monitor. This Phase II project is to enable VAS to further enhance the product based upon our Phase I Study feedback, perform a second usability test at the Cleveland Eye Clinic, and collaborate with a major pharmaceutical company to validate clinical sensitivity and specificity in an 80 DR/DME patient, 12 month Study. Successful completion of this Phase II project will directly lead to commercialization of the product for use in ophthalmic drug trials enabling pharmaceutical companies to collect significantly more data on new retinal compounds at a much lower cost than is currently possible. Such close collaboration with pharmaceutical companies is a crucial next step in the realization of our objective to provide a validated home based diagnostic for physicians to prescribe to their diabetic patients for monitoring and early detection of significant vision changes to maximize the effectiveness of therapeutic intervention and minimize preventable loss of vision. PUBLIC HEALTH RELEVANCE: Over 5 million people in the US today suffer from diabetic retinopathy. A large number of these patients are at high risk for vision loss, even though effective treatments exist, because they fail to receive timely eye exams, and subsequently, do not get medical treatment when it is most effective. This SBIR project seeks to develop a low-cost home vision function monitor which allows physicians to more frequently monitor their diabetic patients by enabling patients to perform their own vision test at home to identify significant vision changes and to get treatment when it can be most effective to prevent vision loss.